Kraniopharyngeom 2007

Author: Ursel Gebhard, Julia Dobke, erstellt am: 2007/05/25, Last modification: 2011/09/19

Kraniopharyngeom 2007 Kraniopharyngeom 2007: Multicenter Prospective Study of Children and Adolescents with Craniopharyngioma
Disease Children and adolescents with craniopharyngioma
Type Prospective, multicentre therapy- and treatment study
Problem / Objectives
  • Randomized investigation of changes in Quality of life (QoL) of children (≥ 5 years of age) and adolescents following incomplete craniopharyngioma resections at primary diagnosis per QoL scores (PEDQOL "physical functions" domain) as measured 60-90 days after surgery and 3 years after randomization; and progression-free and overall survival rates (subgoal assessments) relative to how these parameters relate to postoperative irradiation timing (immediate postsurgery irradiation versus wait-and-see approach + progression-contingent irradiation of residual tumor).
  • Compilation of applied therapy strategies for craniopharyngiomas in children and adolescents using data capture conforming to SIOP brain tumor groups
  • Evaluation of patients’ remission status following the various therapy strategies/modalities for craniopharyngiomas using data detection consistent with SIOP brain tumor groups
  • Investigation of frequency of patients with adenoma of the hypophysis and meningiomas, xanthogranulomas and of sellar and parasellar cystic deformities (arachnoid cysts and Rathke’s pouch cysts)
Therapy / Study arms

Patients with incomplete resection and age >= 5 years will be randomized in two treatment arms:

• Arm I: Planning of localized XRT immediately following surgery (after randomization)
• Arm II: At sign of progression (>25%): localized XRT, (if needed after subsequent surgery) and reference assessment of XRT plans

Patients with complete resection or incomplete resection and age <= 5 years:

• Continuous observation in KRANIOPHARYNGEOM Surveillance Study

Inclusion Criteria

1. Histological diagnosis of the craniopharyngioma
2. Age at diagnosis ≤ 18 years of age
3. Agreement from patient’s parents or legal guardian as well as the patient

For the randomization:

1. Age at primary surgery ≥ 5 years of age
2. Incomplete primary resection
3. Reference radiological confirmation of an incomplete resection
4. Agreement from patient’s parents or legal guardian as well as the patient

Exclusion Criteria

No QoL measurement for randomization (3 months after surgery, 60−90 days).

Recruitment 150
Status 01.10.2007 - 30.09.2013
EudraCT Keine BfArM-Studie
Entry Study Register
Principal Investigator Prof. Dr. med. Hermann L. Müller
Contact UNICODEDECODEERROR: 'ascii' codec can't decode byte 0xfc in position 9: ordinal not in range(128) UNICODEDECODEERROR: 'ascii' codec can't decode byte 0xfc in position 35: ordinal not in range(128)
Weitere Informationen Certified by the German Cancer Society (Seal of Approval A)
Study Protocol Kraniopharyngeom 2007 (4.9 MB)
Please pay attention to the copyright
Link(s) Trial literature on cranyopharingeoma
Sponsoring Deutsche Kinderkrebsstiftung, Bonn